A Multicenter Retrospective Review to Evaluate the Feasibility of Dye Marking Using the Ion Endoluminal System
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 288
- 试验地点
- 1
- 主要终点
- Successful dye injection
研究概览
简要总结
The overall objective of this study is to assess the ability of the Ion Endoluminal System to perform pleural based tissue dye marking in anticipation of a lung resection.
详细描述
This study is a retrospective multicenter chart review of patients who underwent a pleural based tissue dye marking with the Ion Endoluminal System in anticipation of lung resection. The aim of the study is to assess the feasibility of the Ion Endoluminal System to perform pleural based tissue marking. As this is a retrospective study, the Ion dye marking procedure will have been performed according to the physician's standard technique. All consecutive cases in which a dye marking procedure was attempted and/or completed with the Ion Endoluminal System will be included.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is 18 years or older at the time of the procedure.
- •Dye marking attempted/performed using the Ion Endoluminal Platform
排除标准
- •Resection not performed following dye marking procedure
结局指标
主要结局
Successful dye injection
时间窗: Intra-procedure through the release of the final pathology report, approximately 3 days post-procedure
The ability of the investigator to localize the marked lesion during resection, assessed by successful injection of dye, localization of due within the targeted area, and the ability to visualize the dye marking intra-operatively or on resected sample
Pneumothorax
时间窗: Intra-procedure
Incidence of all pneumothoraces related to the Ion procedure
次要结局
- Adverse events(Intra-procedure until the start of the resection procedure)
- Operative time(Intra-operative)
- Procedure time(Intra-procedure)
- Type of resection planned and performed(Intra-operative)
- Conversion to alternate approach or termination of procedure due to localization issues(Intra-operative)